LBBM BIOMEDICAL RESEARCH

LBBM is a Contract Research Organization (CRO) with highly qualified professionals that combine many years of basic and applied research in molecular biology, immunology, genomics and biotechnology with a large expertise in clinical trials conduction, from phases I, II, III and IV, bioequivalence, proof of concept and pharmacodynamic studies. We are located in Buenos Aires, Argentina, one of the largest cities in Southamerica.

The keys for LBBM performance are flexibility and a uniquely close relationship with a large network of investigators and opinion leaders in several areas of health care (HIV-AIDS, Cardiology, Oncology, and Neurology) combined with a constant academic intercourse with national and private universities. This allows us to keep updated with the newest highlights at a scientific level and to provide to our clients the highest management quality, since initiation to close out, guaranteeing the lowest drop out rates that will lead to successful results.

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A Contract Research Organization (CRO) is an organization that offers a wide sprectrum of research services. FDA defines a CRO as "a physical o legal person that assumes, as an independent contractor with a sponsor, one or more of the obligations of the sponsor, such as design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the FDA".

Among the services offered by CROs we can find: product formulation and development, clinical trial management (preclinical, phase I, phase II, phase III, phase IV), laboratory services for processing samples, data analysis and management services for preparation of a report, and many other additional services. CROs offer their clients all stages of a new drug developement from its birth to Regulatory Authorities approval without the drug sponsor having to maintain a special staff for all these services, which frequently are limited in time.

Reasons for outsourcing to contract research organizations

Outsourcing offers a number of advantages to the companies. These include:

Decreases the time required to develop and present a new drug to the market

The sponsor can transform the fixed costs of personnel and facilities for clinical trial management into variable costs

In-house non-availability of services

Knowledge of regulatory processes in different countries

Increased complexity of clinical trials

Increased amount of data required from clinical trials

Multinational and multi-center nature of current clinical trials

Large requirement of patient/volunteer populations

Regionalized diseases

Our in depth understanding of the local regulatory proceedings and timelines and our commitment to meet regulatory standards of the EMEA, FDA and ICH, avoid unnecessary delays in the approval of the studies and allows us to ensure international standards of ethics and data quality.